A Phase II Clinical Study of PDC-748 in Patients With Acute Cough
The pharmacological effects of PDC-748 were tested in numerous in vitro and in vivo studies. The existing pharmacologic findings suggest that PDC-748 possesses certain inhibitory activity to the citric acid- and capsaicin-induced cough reflex in guinea pigs with a dose-dependent manner. Furthermore, a previous Phase I/II uncontrolled, dose-escalating study has shown PDC-748 to be well tolerated and may help to alleviate daytime cough with a dose-responding manner.Hence, PhytoHealth Corporation intends to carry out a Phase II investigation to confirm the preliminary findings using placebo in the comparator group, and to further investigate PDC-748 with a dose escalating manner to establish the dose-response range for its antitussive effect, and if possible, to determine the maximal tolerable dose of PDC-748.
This is a randomized, double-blind, placebo-controlled, dose escalating study to evaluate the safety and efficacy of the escalating dose levels of PDC-748 in patients with acute cough.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Phase II Clinical Study of PDC-748 in Patients With Acute Cough|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547846
|Chang-Gung Memorial Hospital,Taiwan|
|Taipei city/ Taoyuan County, Taiwan,ROC, Taiwan, 105|
|Principal Investigator:||Ying-Huang Tsai, M.D.||Chang Gung Memorial Hospital|
|Principal Investigator:||Ying Huang Tsai, PI||Chang Gung Memorial Hospital|